Cap-assisted necrosectomy: a novel technique increasing safety and efficiency.
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ABSTRACT:
SUBMITTER: Puri N
PROVIDER: S-EPMC5992997 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundCap-assisted endoscopic sclerotherapy is a new interventional therapy for internal hemorrhoids and rectal prolapse under colonoscopy. The proper length of the endoscopic injection needle is the core for performing cap-assisted endoscopic sclerotherapy well with more benefits and less complications. However, no data are currently available to guide endoscopists to consider the length of injection needle before cap-assisted endoscopic sclerotherapy. This study is designed to evaluate the efficacy and safety of cap-assisted endoscopic sclerotherapy with long or short injection needle in the treatment of internal hemorrhoids.MethodsThis is a nationwide multi-center, prospective, single-blind and randomized controlled trial. Patients with grade I-II internal hemorrhoids who have failed to conservative treatments and grade III internal hemorrhoids who are not suitable for surgery or refuse surgery will be included. Participants will be randomized 1:1 into either long or short injection needle group. The primary outcome is the recurrence rate of internal hemorrhoids 24 weeks after cap-assisted endoscopic sclerotherapy. The secondary outcomes are as follows: (1) symptom severity score, (2) three-level EuroQoL five dimensions health scale scores, (3) occurrence of adverse events and severe adverse events, and (4) patients' attitudes toward cap-assisted endoscopic sclerotherapy. Data collection will be conducted before and during operation, the 1st day, 1st week, 2nd week, and 24th week after cap-assisted endoscopic sclerotherapy.DiscussionThe outcome of this study is expected to provide a practical clinical protocol of cap-assisted endoscopic sclerotherapy for patients with internal hemorrhoids and promote the use of this new endoscopic technique.Trial registrationClinicalTrials.gov, NCT03917056. Registered on 12 April 2019.
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Project description:Purpose:In this study, we described our initial experience and analyze the learning curve of segmental renal artery branch clamping with hand-assisted laparoscopic partial nephrectomy (PN) using special instruments. Materials and Methods:We conducted a retrospective review of consecutive cases of hand-assisted laparoscopic PN (LPN) between May 2015 and April 2018. Patient demographics, tumor characteristics, perioperative details, postoperative complications, and warm ischemic time for segmental artery branch clamping were included in our analysis. We used the cumulative sum (CUSUM) method to generate learning curves. Results:Segmental renal artery branch clamping was successfully completed in 16 of 20 patients. The median tumor size was 2.9 cm (range, 1.7-7.0 cm), median operation time was 185 minutes (range, 140-245 minutes), median blood loss was 291 mL (range, 100-600 mL), and median hospital stay was 5 days (range, 4-7 days). The median selective ischemic time was 21 minutes (range, 16-35 minutes). No patient had postoperative complications, acute or delayed bleeding. The median pre- and postoperative serum creatinine levels (0.91 and 0.98 mg/dL, respectively), and the pre- and postoperative estimated glomerular filtration rate (89.7 and 79.6 mL/min per 1.73 m2, respectively) were similar. Upon visual assessment of the CUSUM plots, a downward inflection point for decreasing total operation time was observed in the 9th case and estimated blood loss in the 12th case. Conclusions:Our study shows that segmental renal artery branch clamping hand-assisted LPN for localized renal tumors is feasible, safe, and has a relatively short learning curve.
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